Vascular prosthetic delivery device and method of use

ABSTRACT

Methods for delivering a vascular prosthesis to a treatment site of a subject include advancing the vascular prosthesis, rotating a proximal handle in a first direction about a handle body, shifting the position of a first locking component securing the proximal handle to the push rod from a first position to a second position, rotating the proximal handle in a second direction, releasing the proximal end of the prosthesis from the apex delivery device, shifting the second locking component to disengage the push rod from the handle body; and withdrawing the push rod and the guidewire catheter from within the prosthesis, thereby delivering the vascular prosthesis to the treatment site.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/384,663 filed Dec. 20, 2016, which is a continuation of U.S. patentapplication Ser. No. 14/639,280, filed Mar. 5, 2015, issued as U.S. Pat.No. 9,554,929 on Jan. 31, 2017, which is a divisional of U.S.application Ser. No. 13/829,508, filed Mar. 14, 2013, issued as U.S.Pat. No. 8,998,970 on Apr. 7, 2015, which claims the benefit of U.S.Provisional Application No. 61/623,235, filed on Apr. 12, 2012. Theentire teachings of the above applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION

An aortic aneurysm is an enlargement or bulge in a section of the aorta,which can be life-threatening. Treatment of aortic aneurysms remain achallenge. Endovascular repair has become a viable alternative to openrepair of an aortic aneurysm. An endovascular approach results ininsertion of an endovascular graft to exclude the aneurysm sac fromblood flow. Once in place, the endovascular graft is expanded to createa new path for blood flow. The endovascular graft remains inside theaorta permanently through the use of a metal stent creating a tight fitand seal against the wall of the aorta. Currently, endovascular deliverydevices have limitations on the precise control that the physician hasin placement of the graft at the site of the aneurysm. Thus, there is aneed to develop new and improved delivery devices and methods of usingdelivery devices to treat aortic aneurysms.

SUMMARY OF THE INVENTION

The invention is generally directed to a delivery device for implantinga vascular prosthesis, and to a method of use of the delivery device.

In one embodiment, the delivery device includes a guidewire catheterhaving a proximal end and a distal end, and a delivery assemblyextending about the guidewire catheter. The delivery assembly includes ahandle body, a delivery catheter, a push rod, a proximal handle and alocking mechanism. The handle body has a major longitudinal axis, aproximal end and a distal end. The delivery catheter has a distal endextending from within the distal end of the handle body and about theguidewire catheter. The push rod extends about the guidewire catheterand within the delivery catheter. The push rod is fixed to the guidewirecatheter at a proximal end of the guidewire catheter proximal to thehandle body. The proximal handle extends about the handle body and isaxially fixed to the delivery catheter, wherein the proximal handle isselectively fixed to the push rod, and wherein the proximal handle isrotatable about the handle body and rotation of the proximal handleabout the handle body translates to longitudinal movement of thedelivery catheter and, selectively, of the push rod relative to thehandle body. The locking mechanism at the handle body selectivelyengages the proximal handle with the push rod.

In an embodiment, the delivery device includes an actuator at theproximal handle that selectively disengages the proximal handle from thehandle body, whereby rotation of the proximal handle is independent oflongitudinal movement of the delivery catheter relative to the handlebody. In another embodiment, the proximal handle includes an end thatdefines teeth that move transversely to a major longitudinal axis of thehandle body when the proximal handle is rotated about the handle body.In this embodiment, the delivery device further includes a gear rackextending along the major longitudinal axis of the handle body, alinking gear engaging the teeth of the proximal handle end, the linkinggear being rotatable about an axis transverse to the axis of rotation ofthe proximal handle, and a pinion gear. The pinion gear engages the gearrack and the linking gear, whereby rotation of the proximal handle aboutthe handle body translates to the longitudinal movement of the deliverycatheter and, selectively, of the push rod relative to the handle body.The actuator selectively disengages the linking gear from the piniongear, thereby selectively disengaging rotation of the proximal handlefrom longitudinal movement of the proximal handle along the handle body.

In still another embodiment, the actuator of the delivery deviceincludes an actuator housing, a push-button, a pinion gear extension, aball bearing and a frustoconical center-pin. The actuator housingextends about the handle body and is rotatably linked to the proximalhandle, whereby the actuator housing is movable along the handle bodywithout rotating about the handle body while the proximal handle rotatesabout the handle body. The push-button is located at the actuatorhousing. The pinion gear extension defines a coaxial opening that iscoaxial with the pinion gear and defines at least one lateral openingthat extends laterally from the coaxial opening. The ball-bearing sitsat least partially within the lateral opening and locks the relativerotation of the linking gear and the pinion gear when displaced toextend radially beyond the pinion gear extension. The frustoconicalcenter-pin is biased radially outward from the major longitudinal axisof the handle body and abuts the push-button, whereby the frustoconicalcenter-pin displaces the ball bearing radially outward through thelateral opening and locks the relative rotation of the linking gear andthe pinion gear by the outward bias, thereby causing longitudinalmovement of the proximal handle along the handle body when the proximalhandle is rotated about the handle body and, when the push-button isdepressed, selectively disengages the linking gear from pinion gear,thereby selectively disengaging rotation of the proximal handle from thelongitudinal movement of the proximal handle along the handle body.

Another embodiment of the delivery device of the invention includes adistal grip at the distal end of the handle body, and the lockingmechanism includes a shifting knob, a drive shaft, a drive gear and afirst locking component. The shifting knob is located at the distal gripand is rotatable about the handle body and defines teeth along theinside of the shifting knob that move transversely to the majorlongitudinal axis of the handle body when the shifting knob is rotatedabout the handle body. The locking mechanism has at least two fixedpositions relative to the handle body. The drive shaft has a proximalend and a distal end, wherein the distal end defines teeth that engagedirectly or indirectly, the teeth of the shifting knob, and extend alonga major longitudinal axis of the driveshaft. The drive gear is along thedrive shaft and defines teeth that engage, directly or indirectly, theteeth along the drive shaft, whereby the shifting knob is engaged withthe drive gear at all positions of the shifting knob. The first lockingcomponent extends about the push rod and is linked to the proximalhandle and the drive gear, whereby, in a first position of the shiftingknob, the first locking component engages the proximal handle with thepush rod, and rotation of the shifting knob from the first position to asecond position causes rotation of the drive shaft which, in turn,causes rotation of the drive gear and disengagement of the first lockingcomponent from the push rod, thereby allowing independent movement ofthe delivery catheter along the longitudinal axis of the handle bodyrelative to the push rod when the proximal handle is moved along majorlongitudinal axis of the handle body.

In another embodiment of the invention, the locking mechanism furtherincludes a second locking component. The second locking componentextends about the push rod, is fixed to the handle body, and is linkedto the shifting knob through the drive shaft, whereby rotation of theshifting knob from the first position to the second position causesengagement between the handle body and the push rod, thereby preventinglongitudinal movement of the push rod relative to the handle body whenthe proximal handle is moved along the major longitudinal axis.

In yet another embodiment, the delivery device of the invention includesan apex delivery device that includes an apex clasp assembly andproximal clasp assembly. The apex clasp assembly includes a distalcapture component at a distal end of the guidewire catheter, a proximalcapture component in mateable relation to the distal capture component,and an apex release catheter having a proximal end, wherein the apexrelease catheter extends about the guidewire catheter and is fixed tothe proximal capture component. The proximal clasp assembly includes afixed component at the proximal end of the guidewire catheter and anouter coupling at the proximal end at the apex release catheter inmateable relation with the fixed component of the proximal claspassembly, whereby movement of the outer coupling relative to the fixedcomponent from a first position to a second position will cause relativemovement of the proximal capture component relative to the distalcapture component of the apex clasp assembly.

In still another embodiment, the invention includes the delivery devicethat includes a gear rack, a handle extending about the gear rack anddefining teeth at an end of the handle, the handle being rotatable aboutthe gear rack, a pinion gear that is rotatable about an axis thatintersects with the axis of rotation of the handle and engages the gearrack, a linking gear that selectively rotates with rotation of thepinion gear, an actuator that selectively engages the pinion gear withthe linking gear, and a delivery catheter fixed to the handle, wherebyrotation of the handle selectively moves a delivery catheter relative tothe gear rack upon engagement of the pinion gear with the linking gearby the actuator.

In yet another embodiment, the invention is a method for delivering avascular prosthesis to a treatment site of a subject. The methodincludes advancing the vascular prosthesis, while mounted at a proximalend of the prosthesis to an apex delivery device fixed to a distal endof a guidewire catheter, to a position distal to a vascular treatmentsite of the subject. A proximal handle is rotated in a first directionabout a handle body, having a distal end, of a delivery device throughwhich the guidewire catheter extends. The guidewire catheter is disposedwithin a push rod that also extends through the handle body, wherein theguidewire catheter is fixed to the push rod, whereby rotation of theproximal handle causes longitudinal movement of the guidewire catheterand the push rod along the handle body to thereby at least partiallyadvance the prosthesis to the treatment site, the prosthesis beingadvanced from within an outer catheter extending from a distal end ofthe handle body and about the prosthesis. The position of a firstlocking component securing the proximal handle to the push rod isshifted from a first position to a second position, wherein the firstlocking component disengages the proximal handle from the push rod and asecond locking component engages the push rod with the handle body. Theproximal handle is then rotated in a second direction, whereby adelivery catheter, having a distal end and extending about the push rod,is withdrawn along the push rod, and a delivery sheath extending fromthe distal end of the delivery catheter is at least partially retractedfrom about the prosthesis. The proximal end of the prosthesis is thenreleased from the apex delivery device. The second locking component isshifted to disengage the push rod from the handle body, and the push rodand the guidewire catheter are withdrawn from within the prosthesis,thereby delivering the vascular prosthesis to the treatment site.

The delivery device and method of its use of the invention have manyadvantages. For example, rotation of the proximal handle to therebyadvance the push rod and a vascular prosthesis at the end of the pushrod provides increased control over movement of the vascular prosthesisduring implantation at a treatment site. Further, selective engagementof the proximal handle and the push rod enables disengagement of theproximal handle from the push rod to thereby provide for controlledretraction of a delivery sheath from the vascular prosthesis by rotationof the proximal handle in an opposite direction to that which isemployed to advance the vascular prosthesis to the treatment site. Inaddition, an actuator of the delivery device enables selectivedisengagement of the proximal handle from the handle body, whereby theproximal handle can be moved along the handle body without rotation ofthe proximal handle, thereby providing another degree of freedom ofmovement of the vascular prosthesis during advancement of the vascularprosthesis to the treatment site and during retraction of the deliverysheath from the prosthesis once the prosthesis has been advanced to thetreatment site. The delivery device of the invention also has theadvantage of causing engagement of the push rod with the handle bodyupon disengagement of the proximal handle from the push rod, therebyenabling withdrawal of the delivery sheath from the vascular prosthesiswithout entrainment of the vascular prosthesis while the delivery sheathis being retracted from the vascular prosthesis by movement of theproximal handle. Further, the apex delivery device is controllable at aproximal end of the push rod and guidewire catheter, thereby enablingselective release of a proximal end of the vascular prosthesis at thetreatment site while remaining components of the delivery device remainstationary. In addition, the push rod can be disengaged from both thehandle body and the proximal handle, thereby enabling retraction of thepush rod, guidewire catheter and apex delivery device from within thevascular prosthesis once it has been implanted at the delivery device,thereby minimizing potential disruption of the vascular prosthesis onceit has been implanted.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the delivery device ofthe invention.

FIG. 2 is a perspective view of one embodiment of a shifting knob,driveshaft and actuator, of the invention.

FIG. 3 is a perspective view of the shifting knob and driveshaft of theembodiment shown in FIG. 2.

FIG. 4 is a perspective view of a shifting knob, distal handle, distalhandle nose, and a cross-sectional view, in part, of a handle body anddelivery catheter of another embodiment of the invention.

FIG. 5 is a partial cutaway section of the portion of the embodiment ofthe delivery device of the invention shown in FIG. 4.

FIG. 6 is a partial cutaway section of a detail of a portion of thehandle body, intermediate gear, reduction gear and connecting gear, allof which link the shifting knob with the driveshaft of the embodiment ofthe invention shown in FIG. 4.

FIG. 7 is a partial cutaway view of the embodiment of FIG. 4, showing across-sectional view of the distal handle and a base to which outercatheter is connected at distal handle nose.

FIG. 8 is a partial cutaway, of the embodiment of FIG. 4 showingconstricting rings extending about a delivery catheter.

FIG. 9 is another embodiment of a partial cutaway of the delivery deviceof FIG. 1 showing an actuator and a push button at the proximal end of aslot defined by the handle body.

FIG. 10 is a perspective view of first locking component, and secondlocking component, and their relation to the drive shaft of theembodiment shown in FIG. 1.

FIG. 11 is another representation of a first locking component and asecond locking component, and a first locking component housing and asecond locking component housing stabilizing the spatial relationbetween the first locking component and the second locking component,respectively, relative to the drive shaft of the embodiment of FIG. 1.

FIG. 12A is another perspective view of the embodiment of FIG. 1,showing displacement of the proximal handle and the actuator along thehandle body consequent to rotating of the proximal handle about thehandle body or depressing the push button of the actuator to therebyallow longitudinal movement of the actuator and the proximal handlewithout rotation of the proximal handle.

FIG. 12B is another perspective view of the embodiment of FIG. 1,wherein a proximal handle has been advanced along the handle body of thedelivery system.

FIG. 13 is a detail of the proximal handle and the actuator at thehandle body of the embodiment of the invention shown in FIG. 1, withoutthe actuator housing.

FIG. 14 is a perspective view of the detail of FIG. 13, without the pushbutton of the actuator shown in FIG. 13.

FIG. 15 is a partial cutaway of the embodiment of FIG. 1 showing therelation of the pinion and the linking gear assemblies relative to thefirst locking component housing and the relationship of the firstlocking component housing to the delivery catheter within the housing.

FIG. 16 is a perspective view of the first locking component housing andthe second locking component housing within a cutaway view of the handlebody, along with a perspective view of the linking gear assembly and thepinion gear assembly of the actuator.

FIG. 17 is a side view of the representation of the invention, as shownin FIG. 16.

FIG. 18 is a partial cutaway of the distal end of handle body and secondlocking component shown in FIGS. 16 and 17.

FIG. 19 is a perspective view of a partial cutaway of the actuator shownin FIG. 17.

FIG. 20 is a perspective view of a rack and proximal handle of theembodiment shown in FIG. 1, and an alternate embodiment of the actuatorof the invention, lacking a linking gear assembly.

FIG. 21 is a perspective view, partially transparent, of the embodimentof the pinion gear assembly of FIG. 20.

FIG. 22 is another view of the embodiment represented in FIG. 21.

FIG. 23 is a perspective view of the embodiment shown in FIGS. 21 and22, lacking the upper pinion gear shown in those figures.

FIG. 24 is another embodiment of the representation shown in FIG. 23.

FIG. 25 is a perspective view of one embodiment of a proximal claspassembly of one embodiment of the invention.

FIG. 26 is a partial cutaway of the proximal clasp assembly shown inFIG. 25.

FIGS. 27A-27C are perspective sectional views of the distal end of thedelivery device shown in FIG. 1.

FIG. 28A is a perspective view of the shifting knob in the firstposition, wherein the push rod is fixed to the proximal handle and theprosthesis is undeployed.

FIG. 28B is a detailed perspective view of proximal clasp assembly in afirst position, whereby the apex clasp assembly is unopened.

FIG. 28C is a detailed perspective view of the shifting knob in thefirst position.

FIG. 29A is a perspective view of the delivery device of FIGS. 28A-28Cshowing advancement of the delivery sheath containing the prosthesiswhen the shifting knob is in a second position, wherein the push rod isfixed to the handle body.

FIG. 29B is a detailed perspective view of advancement of the deliverysheath of FIG. 29A.

FIG. 30A is a perspective view of the delivery device of FIGS. 29A, 29Bshowing advancement of the delivery sheath.

FIG. 30B is a detailed perspective view of the shifting knob of FIG. 30Ain a second position.

FIG. 31A is a perspective view of the delivery device of FIGS. 30A, 30B,wherein the delivery sheath has been partially retracted from theprosthesis.

FIG. 31B is a representation of an apex clasp assembly of one embodimentof the invention in a closed position.

FIG. 32A is a perspective view of the delivery device of FIG. 31A,wherein the apex clasp assembly is opened by actuation of the proximalclasp assembly to thereby release the apices of the proximal stent ofthe prosthesis shown in FIG. 32C.

FIG. 32B is a representation of the proximal clasp assembly of FIGS. 25,26, whereby an apex clasp assembly, not shown, has been opened.

FIG. 32C is a representation of the apex clasp assembly of oneembodiment of the invention, in an open position.

FIG. 33A is a perspective view of the delivery device of FIG. 32A,wherein the shifting knob has been moved to the third position, wherebythe push rod has been released from the proximal handle and the handlebody and, wherein the push rod has been retracted from the fullydeployed prosthesis.

FIG. 33B is a perspective view of the shifting knob in the thirdposition as shown in FIG. 33A.

DETAILED DESCRIPTION OF THE INVENTION

While this invention has been particularly shown and described withreferences to example embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

One embodiment, of the delivery device 10 of the invention is shown inFIG. 1. Delivery device 10 includes guidewire catheter 12 (FIGS. 10, 11)having a proximal end and a distal end. “Proximal,” as a term employedherein with reference to the delivery device and its components, meansrelatively close to the surgeon operating the delivery device. “Distal,”as a term employed herein with reference to the delivery device and itscomponents, means relatively distal from the surgeon operating thedelivery device. “Proximal,” as a term employed herein with reference tothe prosthesis, stent-graft and components, means relatively close tothe heart of the patient. “Distal,” as a term employed herein withreference to the prosthesis, stent-graft and components, meansrelatively distal from the heart of the patient. Returning to FIG. 1,delivery device 10 includes delivery assembly 18 that extends about theguidewire catheter (not shown). Delivery assembly 18 includes handlebody 20 having major longitudinal axis 22, proximal end 24 and distalend 26. Delivery catheter 28 (FIG. 9) has distal end 30 (FIG. 27A)extending from within distal end 26 of handle body 20 and about theguidewire catheter (not shown). Push rod 32 extends about guidewirecatheter 12 and within delivery catheter 28 (FIGS. 10, 11). Push rod 32is fixed to guidewire catheter 12 at proximal end 34 of push rod 32proximal to the handle body at pin 192 (FIG. 25). Referring back to FIG.1, proximal handle 36 extends about handle body 20 and is axially fixedto delivery catheter 28. Proximal handle 36 is selectively fixed to pushrod 32, wherein proximal handle 36 is rotatable about handle body 20 androtation of proximal handle 36 about handle body 20 translates tolongitudinal movement of delivery catheter 28 along longitudinal axis 22and, selectively, of push rod 32 relative to handle body 20, as can beseen by comparing FIG. 12A with FIG. 12B. First locking mechanism 38(FIG. 15) at handle body 20 selectively engages proximal handle 36(FIGS. 12A and 12B) with push rod 32.

Distal handle 40 extends about handle body 20 at distal end 26 of handlebody 20 and is distal to shifting knob 42 of first locking mechanism 38((FIG. 15). Distal handle nose 44 (FIG. 1) extends distally from distalhandle 40 and includes flush port 46 for providing fluid communicationbetween a solution source (not shown) and interior components ofdelivery device 10, as necessary, to hydrate contact between componentsof delivery device 10 and a vascular prosthesis (not shown) within asubject during implantation of the vascular prosthesis in the subject.Outer catheter 48 extends from distal handle nose 44 (FIG. 1).

Actuator 80 is linked to proximal handle 36, whereby proximal handle 36can rotate about handle body 20 while push-button 82 at housing 81 ofactuator 80 remains aligned with slot 84 defined by handle body 20.Depression of push-button 82 of actuator 80 selectively disengagesproximal handle 36 from handle body 20, whereby rotation of proximalhandle 20 is independent of longitudinal movement of delivery catheter12 relative to handle body 20 along longitudinal axis 22.

As can be seen in FIG. 2, shifting knob 42 is linked to drive gear 86 bydrive shaft 88. Drive shaft 88 has proximal end 90 and distal end 92,and runs along the interior of the handle body 20 (not shown). As can beseen in FIG. 3, shifting knob 42 is linked to drive shaft 88, in oneembodiment, by intermediate gear 94A, whereby rotation of shifting knob42 about handle body 20 causes rotation of drive shaft 88 by virtue oflinkage between shifting knob 42 and drive shaft 88 by intermediate gear94A. In this embodiment, shifting knob 42 is linked to drive shaft 88indirectly, as opposed to direct linkage. “Direct linkage” would bedirect contact with each other. Shifting knob 42 is rotatably linked todistal handle 40, which is fixed to distal end 26 of handle body 20, asshown in FIG. 1.

In another embodiment, shown in FIGS. 4 and 5, linkage between shiftingknob 42 and drive shaft 88 includes a gear reduction at intermediategear 94B that is linked to coaxial reduction gear 96 which, in turn, islinked to connecting gear 98 that is coaxially linked to drive shaft 88.By virtue of the gear reduction, the rate of rotation of shifting knob42 relative to drive shaft 88 can be controlled by the relativedimensions of reduction gear 96 and connecting gear 98 (FIGS. 5, 6, 7).Typically, the rotation ratio, or reduction ratio, of shifting knob42:drive shaft 88 is in a ratio of between about 1:2 and about 1:6. Therelationship between reduction gear 96 and connecting gear 98 can beseen in greater detail in FIG. 6.

As can be seen in greater detail in FIG. 7, delivery catheter 28 extendsthrough handle body 20, distal handle 40 and distal handle nose 44.Referring back to FIG. 5, outer catheter 48 is linked to base 102,whereby outer catheter 48 is rotatable independently of handle body 20.As shown in FIG. 8, constricting rings 104 extend along the deliverycatheter 28 within handle body 20. As shown in FIGS. 8 and 9,constricting rings 104 have an outside diameter greater than the widthof slot 84, whereby constricting rings 104 will prevent application oflongitudinal compressive force by proximal handle 36 on deliverycatheter 28 from causing delivery catheter 28 to buckle and thereby movethrough slot 84 and outside of handle body 20. Constricting rings 104also have an inside diameter slightly less than the outside diameter ofdelivery catheter 28, whereby constricting rings 104 will have aninterference fit with delivery catheter 28, so that constricting rings104 can move longitudinally along delivery catheter 28 if directed, butotherwise will remain in place relative to delivery catheter 28. Gearrack 106 extends longitudinally within handle body 20. Pin 108 at distalend of handle body 20 extends from distal end 26 of handle body 20 andis selectively slotted within slots 110,112,114 of shifting knob 42.Shifting knob 42 is longitudinally moveable along handle body 20 and isrotatable about handle body 20 sufficient to allow rotation of shiftingknob 42 to move placement of pin 108 within any of slots 110,112,114 ofshifting knob 42, which thereby causes rotation of intermediate gear 94.As a consequence, drive shaft 88 rotates about longitudinal axis 116 ofdrive shaft 88. Shifting knob 42 is a biased against pin 108 by spring118 (FIG. 7).

As can be seen in FIG. 9, gear rack 106 and drive shaft 88 extend thelength of slot 84. FIG. 10 shows the relation between drive shaft 88,push rod 32 and first locking mechanism 38. Push rod 32 extends throughfirst locking mechanism 38 which, in turn, is engaged with drive shaft88 at drive gear 86 of first locking mechanism 38. First lockingmechanism 38 is fixed relative to proximal handle (not shown) at distalbearings 120 through which push rod 32 extends. Distal bearings 120 arelinked to first locking component housing 150 by pins 122. First lockingcomponent 124 of first locking mechanism 38 is fixed relative to distalbearings 120 at distal end 126 and linked to drive gear 86 at proximalend 128, whereby rotation of drive shaft 88 and consequent rotation ofdrive gear 86 will further coil, or reduce coil, of first lockingcomponent 124, resulting in engagement or disengagement, respectively,of locking mechanism 38 and, consequently, proximal handle (not shown),with push rod 32. When first locking mechanism 38 is engaged with pushrod 32, longitudinal movement of proximal handle (not shown) along driveshaft 88 and, thus, handle body 20, will cause longitudinal movement ofpush rod 32 along drive shaft 88 and handle body 20, as can be seen bycomparing FIGS. 12A and 12B.

Referring back to FIGS. 10, 11, drive shaft 88 is rotatably fixed tohandle body 20 (FIG. 9) at driveshaft bearing 130, which is part ofsecond proximal locking component housing 152 at proximal end 90 ofdrive shaft 88. Second locking mechanism 132 includes translating gear134 that is engaged with drive shaft 88 at proximal end 90 of the driveshaft 88 and is rotatably engaged with mechanism bearings 136 (FIG. 11),including proximal bearing 138 (FIG. 10) and distal bearing 140 (FIG.10) which, in turn, are fixed relative to handle body 20 at pins 142.Proximal bearing 138 is radially and axially fixed to handle body 20.Distal bearing 140 is axially fixed to handle body 20. Second lockingcomponent 144 of second locking mechanism 132 is engaged with one ofproximal bearing 138 at proximal end 146 of second locking component144, and engaged with translating gear 134 at distal end 148 of secondlocking component 144, whereby rotation of drive shaft 88 and,consequently, rotation of translating gear 134 will tighten and engage,or loosen and disengage, second locking component 144 with push rod 32.When engaged with push rod 32, second locking component 144 causes pushrod 32 to be fixed in location relative to handle body (not shown). Whenloosened and disengaged from push rod 32, push rod 32 is longitudinallymovable relative to handle body (not shown). The orientation of firstlocking component 124 and second locking component 144 are reversed,whereby rotation of drive shaft 88 in one direction will,simultaneously, cause engagement and disengagement of first lockingcomponent 124 and second locking component 144 with push rod 32,respectively. Disengagement of first locking component 124 from push rod32 is caused by movement of shifting knob 42 from a first positiondefined by pin 108 at slot 110 of shifting knob 42 to second position112, defined by pin 108 at second slot 112 of shifting knob 42 (FIG. 9).The same movement from the first to second position of shifting knob 42will simultaneously cause engagement of second locking component 144with push rod 32, whereby push rod 32 will be fixed in position relativeto handle body 20 at second locking component 144 regardless of movementof proximal handle 36 along longitudinal axis 116 of handle body 20.Referring back to FIGS. 8 and 9, positioning shifting knob 42, so thatpin 108 is at intermediate slot 114 between the first slot 110 andsecond slot 112 of shifting knob 42, will cause both first lockingcomponent 124 and second locking component 144 to be disengaged frompush rod 32.

As can be seen in FIG. 11, first locking component housing 150 fixeslateral movement of first locking component 124 and drive shaft 88, andsecond locking component housing 152 fixes the position of secondlocking component 144 and bearings 138,140 relative to proximal end 90of drive shaft 88, respectively. Further, as can also be seen in FIG.11, apex release catheter 154 extends within push rod 32 and guidewirecatheter 12 extends within apex release catheter 154.

FIGS. 12A and 12B indicate relative movement of actuator 80 and proximalhandle 36 along handle body 20. Rotation of proximal handle 36 abouthandle body 20, when push button 82 is in a first position, as shown inFIGS. 12A and 12B, will cause longitudinal movement of proximal handle20 and actuator 80 along handle body 20. Upon depression of push button82 to a second position essentially flush with actuator housing 81,rotation of proximal handle 36 will not cause longitudinal movement ofproximal handle 36 or actuator along handle body 20. Rather, proximalhandle 36 and actuator 80 will be movable along handle body 20 withoutrotation of proximal handle 36 about handle body 20.

As can be seen in FIGS. 13-15, teeth 156 of proximal handle 36 engageupper linking gear 160 of linking gear assembly 158. Linking gearassembly 158 is engaged with pinion gear assembly 164. Lower linkinggear 162 of linking gear assembly 158 engages upper pinion gear 166 ofpinion gear assembly 164. Pinion gear assembly 164 is linked to firstlocking component housing 150 (FIG. 11) through slot 84. Linking gearassembly 158 and pinion gear assembly 164 are components of actuator 80,referenced with respect to FIG. 1. FIG. 16 is a perspective view ofactuator 80 of FIG. 1 (without housing 81 or pushbutton 82), of firstlocking component housing 150 and second locking component housing 152.

As can be seen in FIG. 17, upper pinion gear 166 is coaxial with lowerpinion gear 168 which, in turn, engages gear rack 106. Referring back toFIGS. 16 and 17, delivery catheter 28 is linked to first lockingcomponent housing 150 and, thus, will move longitudinally along housing150, with movement of proximal handle 36 and actuator 80 as shown inFIG. 1 regardless of whether first locking component 124 is engaged withpush rod 32. Therefore, when upper pinion gear 166 engages lower piniongear 168, rotation of proximal handle 36 (as shown in FIG. 1) abouthandle body 20 will cause rotation of linking gear assembly 158 (FIG.13) and, consequently, rotation of pinion gear assembly 164 (FIG. 13)and movement of pinion gear assembly 164 (FIG. 13) along gear rack 106(FIGS. 16 and 17), and movement of proximal handle 36 (FIG. 1) andactuator 80 (FIG. 17) along handle body 20. Further, while first lockingcomponent 124 is engaged with push rod 32, rotation of proximal handle36 will cause longitudinal movement of push rod 32 along handle body 20.In all cases, movement of proximal handle 36 and actuator 80 alonghandle body 20 will always occur together, and will cause movement ofdelivery catheter 28 longitudinally along handle body 20.

However, as will be further explained below, depression of center pin170 disengages upper pinion gear 166 from lower pinion gear 168. Whenupper pinion gear 166 is disengaged from lower pinion gear 168, rotationof proximal handle 36 about handle body 20 does not cause longitudinalmovement of the proximal handle 36 and actuator 80 along handle body 20.Further, longitudinal movement of proximal handle 36 and actuator 80along handle body 20 can be obtained simply by moving proximal handle 36and actuator 80 along handle body 20 without rotation of proximal handle36 about handle body 20 (FIGS. 1, 12A and 12B).

FIG. 18 shows placement of the second locking component housing 152within proximal end 24 of handle body 20 and second locking component144 extending between bearings 138,140. As stated above, rotation oftranslating gear 134 by virtue of rotation of drive shaft 88 (FIGS. 10,11) will cause engagement or disengagement of second locking component144 with push rod 32 extending through second locking component 144 and,consequently, engagement and disengagement of push rod 32 with proximalend 24 of handle body 20.

FIG. 19 is another perspective view of linking gear assembly 158 andpinion gear assembly 164 of actuator 80 (FIG. 1).

As an alternative embodiment, shown in FIG. 20, push button 82 restsatop center-pin 170, which extends through upper pinion gear 166. As canalso be seen in FIGS. 20 and 21, lower pinion gear 168 is engaged withgear rack 106 and includes pinion gear extension 169 that is axiallyaligned with lower pinion gear 168 that is axially aligned with upperpinion gear 166. Lower portion 172 of pinion gear 168 extends intoopening 174 (FIG. 11) defined by first locking component housing 150(FIG. 11), thereby fixing the position of pinion gear assembly 164relative to first locking component housing 150 (FIG. 11), distalbearing 120 (FIG. 11), first locking component 124 and drive gear 86,all of which are shown, in a previous embodiment, in FIG. 11.

FIG. 21 is a perspective view showing engagement of lower pinion gear168 with gear rack 106 and frustoconical portion 176 of center-pin 170.As can be seen in FIGS. 22 and 23, ball bearings 178 extend throughopenings 180 defined by pinion gear extension 169 and, when center pin170 is in an extended position, as shown in FIG. 22, frustoconicalportion 176 of center pin 170 forces ball bearings 178 outwardly andinto interfering relation with openings 182 (FIG. 21) defined by upperpinion gear 166 (FIGS. 21 and 22) thereby engaging upper pinion gear 166with lower pinion gear 168. When center pin 170 is actuated bydepressing button 82 (FIG. 1), as shown in FIG. 23, ball bearings 178are forced inward by rotation of upper pinion gear 166 (FIG. 22)relative to lower pinion gear 168 (FIG. 22), whereby upper pinion gear166 is no longer engaged with lower pinion gear 168. Center-pin 170 isbiased in an outward position, whereby upper pinion gear 166 is directedinto engagement with lower pinion gear 168 by spring 184 located at thebase of center pin 170 (not shown in FIG. 22 or 23).

As can be seen in FIG. 32C, nose cone 50 is fixed to guidewire catheter12 at a distal end 16 of the guidewire catheter 12. Vascular prostheticcomponent 58 is disposed within delivery device 10 proximal to nose cone50 (FIG. 27A).

FIGS. 25 and 26 show perspective and cut-away views, respectively, ofthe proximal clasp assembly 184 component of the invention. As can beseen in FIG. 25, outer coupling 186 is slideable along proximal end 34of push rod 32. Fixed component 188 is fixed to the proximal end of theguidewire catheter by pin 192. Outer coupling 186 and fixed component188 are in mating relation at juncture 190. Spring 194 within outercoupling 186 biases outer coupling 186 against fixed component 188.Proximal clasp assembly 184 is moved from a first position, shown inFIGS. 25, 28B to a second position, shown by applying pressure totongues 196 on either side of outer coupling 186, and directing outercoupling 186 distally in sufficient degree to allow rotation of outercoupling 186 ninety (90) degrees and then retracting outer coupling 186so that tongues 196 of outer coupling 186 align between tongues 198 offixed component 188, as shown in FIG. 32B. Movement of outer coupling186 from the first position, shown in FIG. 25, to the position shown inFIG. 32B, causes opening of apex clasp assembly 52, whereby proximalcapture component is retracted from a first position that is in matingrelation to the distal capture component 56 of apex clasp assembly 52shown in FIG. 31B, to a second position, shown in FIG. 32C, whereinproximal capture component 54 is no longer in mating relation withdistal capture component 56. Proximal movement of outer coupling 186 ofproximal clasp assembly 184 (FIGS. 25, 28B, 32B) relative to a fixedcomponent 188 to separate proximal capture component 54 (FIG. 31B) fromdistal capture component 56 (FIGS. 31B, 32C) releases apices 68 of stent66 at proximal end 60 of vascular prosthetic component 58.

FIGS. 27A-27C are cross sectional views of a portion of delivery device10 of the invention showing a vascular prosthetic component 58 in anundeployed state within a distal end 202 of delivery device 10.Specifically, as shown in FIG. 27A, vascular prosthetic component 58 iswithin delivery sheath 200. Distal end 62 of vascular prostheticcomponent 58 abuts buttress 204. Buttress 204, in turn, is mated to pushrod 32 at distal end 206, proximal end 60 of vascular prostheticcomponent 58 captured at apices 68 of proximal stent 66 with apex claspassembly 52 when apex clasp assembly 52 is in a closed position, asshown in FIG. 27A. Apex class assembly 52 includes distal capturecomponent 56 at distal end 16 of guidewire catheter 12, and proximalcapture component 54 is in mateable relation to distal capture component56, and attached to distal end 210 of apex release catheter 154. Apexrelease catheter 154 extends about guidewire catheter 12, and both apexrelease catheter 154 and guidewire catheter 12 extend through vascularprosthetic component 58 and push rod 32 to proximal clasp assembly 184(FIG. 26). Delivery sheath 200 is fixed at its proximal end to deliverycatheter 28 at distal end 30 and extends about vascular prostheticcomponent 58 to apex clasp assembly 52, as can be seen in FIG. 27C.Returning to FIG. 27, nose cone 50 is fixed at guidewire catheter 12distally to distal capture component 56 of apex clasp assembly 52. Outercatheter 48 extends from distal handle nose 44 (FIG. 1), and aboutdelivery catheter 28 and delivery sheath 200, to nose cone 50.

As shown in FIGS. 28A-33B, a method for delivering a vascular prosthesisto a treatment site of the subject employing a delivery device of theinvention includes advancing vascular prosthesis 58, while prosthesis 58is mounted to apex clasp assembly 52 at proximal end 60 of theprosthesis 58. Proximal apex clasp assembly 184 is in a first positionshown in FIG. 28B, whereby apex clasp assembly 52 is closed (FIG. 31B).Apices of vascular prosthesis 58 are secured at apex clasp assembly 52when proximal clasp assembly 184 is in the first position. Apex claspassembly 52 is, in turn, fixed to distal end 16 of guidewire catheter12, shifting knob 42 is in a first position when pin 108 is in slot 110(FIG. 28C), causing push rod 32 to move with longitudinal movement ofproximal handle 36. Prosthesis 58 is advanced to a position distal to avascular treatment site of the subject by rotation of proximal handle 36in a first direction about handle body 20, having distal end 26, ofdelivery device 10 through which guidewire catheter 12 extends.Guidewire catheter 12 is disposed within push rod 32 that also extendsthrough handle body 20, wherein guidewire catheter 12 is fixed to pushrod 32, such as at a proximal end of guidewire catheter 12 or push rod32 by pin 192 (FIG. 25), whereby rotation of proximal handle 36 causeslongitudinal movement of guidewire catheter 12 and push rod 32 alonghandle body 20 to thereby at least partially advance prosthesis 58 fromouter catheter 48 as can be seen in FIGS. 29A-29B. Optionally, pushbutton 82 of actuator 80 can be depressed to disengage rotation ofproximal handle 36 from longitudinal movement of proximal handle 36along handle body 20, to thereby allow manual advancement of vascularprosthesis 58 to the vascular treatment site of the subject withoutrotation of proximal handle 36 about handle body 20.

Shifting knob 42 is shifted from a first position, wherein first lockingcomponent 124 (FIGS. 10, 11) secures proximal handle 36 to push rod 32,to a second position, whereby first locking component 124 (FIGS. 10, 11)disengages proximal handle 36 from push rod 32 and second lockingcomponent 144 (FIGS. 10, 11) engages push rod 32 with handle body 20 atproximal end 24 of handle body 20.

As can be seen in FIGS. 31A and 31B, proximal handle 36 can then berotated in a second direction, while actuator push button 82 is notdepressed, whereby delivery catheter 28, having a distal end 30 (FIG.24A) and extending about push rod 32, is withdrawn along push rod 32,and delivery sheath 200 extending from distal end of the deliverycatheter (FIGS. 4 through 9) is at least partially retracted from aboutprosthesis 52. Optionally, push-button 82 of actuator 80 can bedepressed, thereby disengaging rotation of proximal handle 36 fromhandle body 20, to thereby fully retract of delivery sheath 200 fromvascular prosthesis 58 without rotation of proximal handle 36 abouthandle body 20, as can be seen in FIG. 32A.

Proximal clasp assembly 184 is then actuated by compressing outercoupling 186 and moving outer coupling 186 first distally, then rotatingouter coupling 186 ninety degrees, and thereafter retracting outercoupling 186 to a second position, shown in FIG. 32B, thereby retractingapex release catheter 154 within push rod 32 (FIGS. 10, 11) andretracting proximal capture component 54 from distal capture component56. Apices 68 of stent 66 at the proximal end 60 of vascular prosthesis58 are released from apex clasp assembly 52, and prosthesis 58 isthereby released from the delivery device 10, as can be seen in FIG.32C. Shifting knob 42 is then moved from the second position to thethird position, wherein pin 108 is located in slot 114 between firstslot 110 and second slot 112, as can be seen in FIG. 33B, therebydisengaging push rod 32 from handle body 20. Push rod 32 and guidewirecatheter 12 are then withdrawn from vascular prosthesis 58 by pullingpush rod 32 through handle body 20, thereby completing delivery ofvascular prosthesis 58 to the treatment site, as can be seen in FIG.33A.

While this invention has been particularly shown and described withreferences to example embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims

The relevant portion of all references cited herein and U.S. Pat. No.8,070,790 and U.S. patent application Ser. No. 12/459,387 (PublicationNo. 20100030255) and Ser. No. 12/723,431 (Publication No. 20100234932)are incorporated by reference in their entirety.

What is claimed is:
 1. A delivery device, comprising: a) a handle body(20), having a longitudinal axis (22), a proximal end, and a distal end;b) a gear rack (106) extending within the handle body (20); c) aproximal handle (36) extending about the gear rack (106) and definingteeth (156) at an end of the proximal handle (36), the proximal handle(36) being rotatable about the gear rack (106); d) a delivery catheter(28) fixed to the proximal handle (36), whereby rotation of the proximalhandle (36) selectively moves the delivery catheter (28) relative to thegear rack (106) upon engagement of a pinion gear assembly (164) with alinking gear assembly (158) by an actuator (80); e) a distal handle (40)that extends around the handle body (20) at the distal end (26) of thehandle body (20); f) an outer catheter (48) extending distally from thedistal handle (40), and about the delivery catheter (28) in a first,retracted position; g) an actuator (80) fixed to the proximal handle(36) that selectively engages rotation of the proximal handle (36) tothereby cause longitudinal movement of the proximal handle (36) alongthe handle body (20), the actuator (80) including i. a linking gearassembly (158), including an upper linking gear (160) engaged with theteeth (156) of the proximal handle (36), a lower linking gear (162), theupper linking gear (160) and the lower linking gear (162) being fixed toeach other and having a common axis of rotation that is normal to thelongitudinal axis of the handle body (20), and ii. a pinion gearassembly (164), including an upper pinion gear (166) engaged with thelower linking gear (162), the upper pinion gear (166) defining an upperpinion gear orifice and rotatable about a pinion gear axis, a lowerpinion gear (168) axially aligned with the upper pinion gear (166) anddefining a lower pinion gear orifice, the lower pinion gear (168)including a lower portion (172) extending toward the longitudinal axisof the handle body (201, a gear portion engaged with the gear rack(106), and a pinion gear extension (169) that extends within the upperpinion gear orifice, wherein the pinion gear extension (169) defines apinion gear extension orifice, the pinion gear extension (169) and theupper pinion gear (166) together defining an opening (182) that, whenoccupied, prevents rotation of the upper pinion gear (166) and the lowerpinion gear (168) relative to each other, the pinion gear extensionfurther defining a plurality of fenestrations (180), a ball bearing(178) in at least one of each fenestration (180), the ball bearing (178)having a diameter greater than a thickness of a wall defining theplurality of fenestrations (180), a center pin (170) moveable along thepinion gear axis and within the upper pinion gear orifice, the lowerpinion gear orifice and the pinion gear extension orifice, the centerpin (170) including a frustoconical portion (176) between a base portionhaving a first diameter within the lower pinion gear orifice and asecond diameter that is less than the first diameter, and located in theupper pinion gear orifice, whereby movement of the frustoconical portion(176) of the center pin (170) causes radially outward displacement ofthe ball bearing (178) into the opening (182), thereby causing aninterfering relation between rotation of the upper pinion gear (166) andthe lower pinion gear (168), and a spring (184) at the lower pinion gear(168) that provides bias to the center pin (170) radially outward fromthe longitudinal axis of the handle body (20), whereby the ball bearing(178) is biased toward the opening (182), thereby causing theinterfering relation between the upper pinion gear (166) and the lowerpinion gear (168); and h) a push rod (32) having a proximal end (34),the push rod (32) being selectively fixed to the proximal handle (36)and extending within the delivery catheter (28).
 2. The delivery deviceof claim 1, wherein the actuator (80) disengages the proximal handle(36) of the handle body (20), whereby rotation of the proximal handle(36) is independent of longitudinal movement of the delivery catheter(28) relative to the handle body (20) along the longitudinal axis (22)of the handle body (20).
 3. The delivery device of claim 2, furtherincluding a first locking mechanism (38) that selectively engages thepush rod (32).
 4. The delivery device of claim 3, wherein the firstlocking mechanism (38) is fixed relative to the proximal handle (36). 5.The delivery device of claim 4, further including a) a shifting knob(42) at the distal handle (40) that is rotatable about the handle body(20); and b) a drive shaft (88) that links the shifting knob (42) withthe first locking mechanism (38), whereby rotation of the shifting knob(42) actuates the first locking mechanism (38) to thereby engage ordisengage the proximal handle (36) with the push rod (32), and whereinengagement of the proximal handle (36) with the push rod (32) causesdistal advancement of the proximal handle (36) to move the push rod (32)and the delivery catheter (28) from the first, retracted position to asecond, extended position distal to the outer catheter (48).
 6. Thedelivery device of claim 5, further including a second locking mechanism(132) proximal to the first locking mechanism (38), whereby rotation ofthe shifting knob (42) in a direction that disengages the proximalhandle (36) from the push rod (32) will cause engagement of the secondlocking mechanism (132) with the push rod (32).
 7. The delivery deviceof claim 6, wherein the second locking mechanism (132) is fixed to thehandle body (20), whereby locking the second locking mechanism (132)with the push rod (32) also locks the push rod (32) to the handle body(20), and whereby subsequent proximal movement of the proximal handle(36) will cause retraction of the delivery catheter (28) from the pushrod (32) to a third position.
 8. The delivery device of claim 7, whereinrotation of the shifting knob (42) to a position intermediate to lockingthe first locking mechanism (38) to the push rod (32) and locking thesecond locking mechanism (132) to the push rod (32) causes the push rod(32) to be locked to neither the first locking mechanism (38) nor thesecond locking mechanism (132), whereby the push rod (32) can beretracted independently of movement of the proximal handle (36).
 9. Thedevice of claim 8, further including, a) a guidewire catheter (12)having a distal end (16), the guidewire catheter (12) extending withinthe push rod (32); b) an apex release catheter (154) having a distal end(210), the apex release catheter extending about the guidewire catheter(12) and within the push rod (32); and c) an apex clasp assembly (52)that includes, i. a distal capture component (56) proximal to the distalend (16) of the guidewire catheter (12); and ii. a proximal capturecomponent (54) that is fixed to the distal end (210) of the apex releasecatheter (154) and is mateable to the distal capture component (56). 10.The device of claim 9, further including a proximal clasp assembly (184)at the proximal end (34) of the push rod (32), proximal to the handlebody (20), wherein the proximal clasp assembly (184) includes a) a fixedcomponent (188) that is fixed to the distal end (16) of the guidewirecatheter (12), and b) an outer coupling (186) distal to the fixedcomponent (188), the outer coupling (186) being fixed to the apexrelease catheter (154) and in interfering relation with the fixedcomponent (188) in a first position that locks the proximal capturecomponent (54) in mated relation with the distal capture component (56)in a first position, and is moveable from the first position to a secondposition relative to the fixed component (188) that moves the proximalcapture component (54) away from distal capture component (56) and outof mated relation with the distal capture component (56).
 11. Thedelivery device of claim 10, wherein the proximal capture component (54)includes distally-extending tines and the distal capture component (56)defines recesses that receive the tines in mating relation, wherebyapices (68) of an exposed stent (66) of a vascular prosthetic component(58) loaded within the delivery device are captured by the apex claspassembly (52) prior to implantation, and whereby the movement of theouter coupling (186) of the proximal clasp assembly (184) from the firstposition to the second position releases the exposed stent (66) duringimplantation of the vascular prosthetic component (58) at a surgicalsite.
 12. The delivery device of claim 11, further including a nose cone(50) at the distal end (16) of the guidewire catheter (12) and distal tothe distal capture component (56).